Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (Hardcover)

PART ONE: Setting the Scene.- Introduction.- The Context and the Problem in Focus.- Secondary Analysis of Clinical Trial Data - A Primer.- PART TWO: Analysis de lege lata,- Legal Sources of Control over and Access to Clinical Trial Data under the EU Applicable Framework.- Implications of IPD Disclosure for Statutory Innovation Incentives PART THREE: Analysis de lege ferenda.- Defining the Intervention Logic of Access-To-Data Measures - A Problem Analysis.- Access to Clinical Trial Data as a Case on R&D Externalities - A Theoretical Framework.- IPD as a Research Resource - Exclusively Controlled or Readily Accessible?.- Evaluating Legislative Options.- Final Conclusions and the Outlook.